Effectiveness of Sitagliptin in Glycemic Control in Real World

NCT ID: NCT01316835

Last Updated: 2011-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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This study will evaluate whether the addition of sitagliptin treatment provides additional decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic control on their current oral anti-glycemic therapy in real world practice.

Detailed Description

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To explore the change of glycemic control (HbA1c or FPG) before and after 24 weeks of Sitagliptin treatment in Type 2 Diabetic patients who have started Sitagliptin as add on therapy during the index period and received Sitagliptin continuously\* for at least 24 weeks.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Type 2 Diabetes Mellitus, No treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. All subjects diagnosed of type 2 diabetes (ICD-9 code= 250.0; 250.1; 250.2; 250.3; 250.4; 250.5; 250.6) and have been followed up regularly in the study center who have started to receive Sitagliptin as an add-on treatment to their prior regimen during the index period
2. Subjects must be on a stable dose of all antidiabetic regimens, with stable dose defined as "at least 3 months with no therapy/dose change" prior to adding sitagliptin
3. Subjects in whose medical records a minimum core data set can be found.
4. Outpatient

Exclusion Criteria

1. Subjects with type 1 DM
2. Subjects have been treated with insulin regularly
3. Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions
4. Subjects who participated in a clinical trial or other clinical study during the index period
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Gung Memorial Hospital

Principal Investigators

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Ching-Jung Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospita

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ching-Jung Hsieh, MD

Role: CONTACT

886-7-7317123

Facility Contacts

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Ching-Jung Hsieh, MD

Role: primary

886-7-7317123

Other Identifiers

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99-2717B

Identifier Type: -

Identifier Source: org_study_id

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